Safety of AMD070 When Administered Alone or Boosted With Low-Dose Ritonavir in HIV Uninfected Men

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

Most currently approved anti-HIV drugs work by stopping the replication of HIV after it has entered cells. AMD070 (also known as AMD11070) is designed to block HIV from entering cells and may be effective in treating patients who have developed resistance to or are unable to take other anti-HIV drugs. This study will evaluate the safety of different doses of AMD070 along with AMD070 boosted with ritonavir (RTV) in HIV uninfected men.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: AIDS Clinical Trials Group
• Treatments: Ritonavir

Criteria

Inclusion Criteria for all participants:

• HIV uninfected males in good general health

• Normal electrocardiogram (EKG) and lab values

• Body weight within 33% of ideal weight for height within 28 days of study entry

• Willing to refrain from exercise for 24 hours prior to study entry

• Willing to use acceptable forms of contraception

Inclusion Criteria for Group 3's Additional Study:

• Willing to refrain from consumption of alcohol and grapefruit juice for the duration of the study

Exclusion Criteria for all participants:

• Prescription medications, herbal supplements, or aspirin within 7 days of study entry

• Nonsteroidal anti-inflammatory drugs, over-the-counter medications, and other supplements (including multivitamins) within 1 day of study entry

• Active infection or acute illness within 14 days of study entry

• Drug or alcohol abuse or dependence

• Known sensitivity to AMD070

• History of gastrointestinal bleeding or ulcer

• Any medical or psychological condition that, in the opinion of the investigator, would interfere with study participation

Exclusion Criteria for Group 3:

• Immunizations within 30 days of study entry

• Radiation therapy, cytotoxic chemotherapeutic agents, or immunomodulating agents within 30 days of study entry

• Chronic diarrhea for more than 4 weeks prior to study entry

• Heart conduction abnormalities, heart arrhythmias, cardiomyopathy, any repolarization delay, or other risk factors for heart failure and hypokalemia

Exclusion Criteria for Group 3's Additional Study:

• Grade 3 or 4 adverse event while participating in Group 3

• Consumption of alcohol within 48 hours of study entry